BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 8770034 · Received July 8, 2019

    Report

    Report Number
    3004976965-2019-00022
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 27, 2019
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RECEIVED AT VIANT FOR EVALUATION. A CUP SIMULANT WAS ATTACHED AND THE IMPACTION PLATE IMPACTED, AS DEPICTED IN THE INSTRUCTIONS FOR USE (IFU) SENT WITH THIS LOT. THE CUP SIMULANT COULD BE ATTACHED AND RATCHETED TIGHT, AS INTENDED, HOWEVER, ONCE IMPACTED THE RATCHET KEY LOOSENED UP A FEW TEETH, WHICH LOOSENS THE CUP, WHICH IS NOT INTENDED UNTIL IMPACTION IS COMPLETE. THIS CONFIRMS THE COMPLAINT. UPON CLOSER EXAMINATION IT WAS OBSERVED THAT THE WELD ADJOINING THE RATCHET HOUSING TO THE OFFSET CUP IMPACTOR (OCI) BODY WAS FRACTURED ALL AROUND AND THE RATCHET HOUSING SLIGHTLY LOOSE, LIKELY LEADING TO THE CUP LOOSENING DURING IMPACTION. THERE WERE SEVERAL SCRATCHES AND GOUGES ON THE RATCHET HOUSING, AND A FEW ON THE TRIGGER PLATE, LIKELY FROM BEING IMPACTED WHICH IS NOT THE INTENDED USE. THERE WAS UNINTENDED USE OBSERVED ON THE RATCHET TEETH AS WELL AS ON THE OCI BODY IN THE AREA OF THE RATCHET HOUSING. ADDITIONALLY, THERE WERE OTHER AREAS THROUGHOUT THE OCI WHERE UNINTENDED USE WAS ALSO OBSERVED: ALL ALONG THE OCI BODY, BETWEEN THE LATCH PLATE PINS THAT HOLD THE CHAIN TO THE OCI BODY AND THE REMOVABLE NOSE, THERE WERE SEVERAL SCRATCHES AND GOUGES CONSISTENT WITH OFF-AXIS IMPACTION, WHICH IS NOT INTENDED, AS THE OCI IS INTENDED TO BE IMPACTED ON THE IMPACTION PLATE; THE TWO (2) LARGE LATCH PINS ON THE CHAIN ASSEMBLY THAT CONNECT THE OCI BODY WITH THE CHAIN ASSEMBLY WERE SEVERELY DEFORMED AND THERE WERE SEVERAL GOUGES IN THE AREA THAT WERE NOT CONSISTENT WITH INTENDED USE; THE OCI BODY HAD HAIRLINE FRACTURES ON EACH SIDE, WHERE THE TWO (2) LONG LATCH PLATE PINS COME UP TO HOLD THE LARGE CHAIN ASSEMBLY PINS IN PLACE. OTHER OBSERVATIONS: THERE WERE MANY SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; EACH OF THE SHORT PIN/FORK WELDS ON THE CARDAN JOINT NEAREST THE THREADED END WERE FRACTURED; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. NO DISCREPANCIES WERE DISCOVERED DURING REVIEW OF PRODUCT RECORDS. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED. A CUP SIMULANT COULD BE ATTACHED BUT WOULD LOOSEN UPON IMPACT, WHICH IS NOT INTENDED. THE WELD ADJOINING THE RATCHET HOUSING AND OFFSET CUP IMPACTOR (OCI) BODY WAS FRACTURED ALL AROUND AND THE RATCHET HOUSING SLIGHTLY LOOSE, LIKELY LEADING TO THE CUP LOOSENING DURING IMPACTION. THERE WERE SIGNS OF UNINTENDED USE THROUGHOUT THE COMPLAINT SAMPLE, INCLUDING ON AND AROUND THE RATCHET HOUSING, LIKELY LEADING TO THIS FRACTURE, AS WELL AS THE FRACTURE OBSERVED ON THE OCI BODY. NO FURTHER INVESTIGATION IS REQUIRED WITH REGARD TO THIS COMPLAINT. VIANT WILL CONTINUE TO MONITOR FOR TRENDS. EVENT NOTIFICATION WAS RECEIVED 27-MAY-2019 WHICH DID NOT MEET REPORTABILITY REQUIREMENTS AT THE TIME WITH THE INFORMATION AVAILABLE. HOWEVER, THE DEVICE WAS RECEIVED 30-MAY-2019 WHICH CONTAINED A FRACTURE AND HENCE MET THE REPORTING REQUIREMENTS, HOWEVER THIS FRACTURE WAS NOT OBSERVED UNTIL (B)(6) 2019, UPON CLOSER EXAMINATION OF THE COMPLAINT SAMPLE. COMPLAINT INFORMATION RECEIVED FROM DISTRIBUTOR, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE HANDLE WOULD NOT HOLD TRIAL IMPLANT OR CUP IMPLANT TIGHTLY. NO ADVERSE EVENTS NOR PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE MALFUNCTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561318 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC3206028

    Patients

    Seq Age Sex Outcome Treatment
    1